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NCT Number: NCT07512921

Matching Primary Tumor and Blood Gene Expression Analysis of HPV-negative Squamous Head and Neck Cancers

The goal of this observational study is to learn whether a blood test can show the same biological features as the tumor in people with head and neck cancer that is not caused by HPV. These cancers often have different biological types, and these types may help predict how the cancer will behave. Today, these types can only be found by studying tumor tissue. This study wants to see if a simple blood sample can give the same information.

The main questions the study aims to answer are:

* Can a blood test identify the same tumor type that researchers find by studying tumor tissue under a microscope and through genetic testing? * Can these blood test results help predict how people may do after finishing treatment?

Researchers will not assign treatments. All participants will receive the treatments recommended by their own care team as part of routine care.

Participants will:

* Give a blood sample before starting treatment. * Give another blood sample about 3 months after finishing treatment. * Allow researchers to use a sample of their tumor (already collected as part of standard care) for genetic testing. * Continue routine follow-up visits with their care team.

About 300 adults with locally advanced, HPV-negative head and neck cancer (affecting the mouth, throat, voice box, or hypopharynx) will take part. Only people who are receiving treatment to cure their cancer can join. People with returning cancer or cancer that has already spread cannot join.

Researchers will study:

* Gene activity in tumor tissue * Gene activity in blood * Patterns in blood fragments and small molecules * Digital images of tumor samples using computer-based tools

The study will compare these different types of information to see whether a blood test can reliably show the tumor's biological type. If it can, this could make it easier to monitor the cancer after treatment and may help guide future care.

This study does not test any new drug or treatment. It collects information that may help improve care for people with HPV-negative head and neck cancer in the future.

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Key information

Conditions

Head and Neck (HNSCC) Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pathologic diagnosis of HNSCC
  • Primary HNSCC arising from the following sites of head and neck: oral cavity, p16-negative oropharynx, hypopharynx, larynx
  • Stage III-IVa/b according to the eighth edition of AJCC/UICC classification
  • Treatment with curative intent
  • Unequivocal clinical and/or radiological absence of metastatic disease
  • Patient ability and availability to comply with study protocol procedures.-

Exclusion criteria

  • Recurrent/metastatic HNSCC
  • p16+ oropharyngeal squamous cell carcinoma
  • Evidence of high-risk HPV infection at tumor level
  • Cancer of unknown primary site
  • Non-squamous head and neck cancers (e.g., lymphoma, sarcoma, melanoma, salivary gland cancers)
  • Skin squamous cell carcinoma from the skin of the head and neck
  • Nasopharyngeal carcinoma
  • Sinonasal/paranasal cancers
  • Insufficient data about previous medical history.

Treatment and study plan

Standard of Care (Investigator Choice)

Other

This study does not include any medical treatment or experimental therapy. The only study-specific procedures are the collection and analysis of biological samples.

The intervention consists of:

  • Two blood draws: one before the start of routine cancer treatment and one about 3 months after treatment is completed.
  • Use of stored tumor tissue collected previously as part of standard medical care.
  • Laboratory analyses of these samples to study gene activity, DNA fragments, DNA methylation, and circulating microRNAs.
  • Digital analysis of tumor slides using computer-based tools to identify biological patterns.

These procedures are used only to compare blood-based markers with tumor-based markers. They do not change or influence the participant's medical treatment, which is decided entirely by their usual care team.

Primary outcomes

  1. Accuracy of a blood profile (b-OMICS) in identifying the tumor tissue subtypes (t-OMICS) in loco-regionally advanced HPV-negative HNSCC patients.

    Time frame: 6 months

    AUROC (area under receiver operating characteristics) of b-OMICS (newly identified and developed in the current project) in diagnosing Cl2-Cl3 on t-OMICS (based on the transcriptomic model developed by De Cecco et al. Oncotarget 2015) in stage III-IVa/b (AJCC/UICC eighth edition) HPV-negative HNSCC patients treated with curative intent.

Secondary outcomes

  1. OS of HPV-negative HNSCC patients based on their t-OMICS and b-OMICS.

    Time frame: 6 months

    Overall survival (OS) stratified according to t-OMICS (Cl2-Cl3 vs. others; presence or absence of b-OMICS signature).

  2. DFS of HPV-negative HNSCC patients based on their t-OMICS and b-OMICS.

    Time frame: 6 months

    Disease-free survival (DFS) stratified according to t-OMICS (Cl2-Cl3 vs. others; presence or absence of b-OMICS signature).

Other outcomes

  1. Sensitivity of a blood GE profile (b-OMICS) in identifying the digital pathology model in loco-regionally advanced HPV-negative HNSCC patients

    Time frame: 6 months

    Sensitivity of b-OMICS (newly identified and developed in the current project) in diagnosing the digital pathology model (newly identified and developed in the current project) in stage III-IVa/b (AJCC/UICC eighth edition) HPV-negative HNSCC patients treated with curative intent

  2. Specificity of a blood GE profile (b-OMICS) in identifying the digital pathology model in loco-regionally advanced HPV-negative HNSCC patients

    Time frame: 6 months

    Specificity of b-OMICS (newly identified and developed in the current project) in diagnosing the digital pathology model (newly identified and developed in the current project) in stage III-IVa/b (AJCC/UICC eighth edition) HPV-negative HNSCC patients treated with curative intent

  3. Sensitivity of a digital pathology model in identifying the t-OMICS in loco-regionally advanced HPV-negative HNSCC patients

    Time frame: 6 months

    Sensitivity of digital pathology model (newly identified and developed in the current project) in diagnosing Cl2-Cl3 on t-OMICS (based on the transcriptomic model developed by De Cecco et al. Oncotarget 2015) in stage III-IVa/b (AJCC/UICC eighth edition) HPV-negative HNSCC patients treated with curative intent

  4. Specificity of a digital pathology model in identifying the t-OMICS in loco-regionally advanced HPV-negative HNSCC patients

    Time frame: 6 months

    Specificity of digital pathology model (newly identified and developed in the current project) in diagnosing Cl2-Cl3 on t-OMICS (based on the transcriptomic model developed by De Cecco et al. Oncotarget 2015) in stage III-IVa/b (AJCC/UICC eighth edition) HPV-negative HNSCC patients treated with curative intent

  5. DFS of HPV-negative HNSCC patients based on digital pathology model.

    Time frame: 6 months

    DFS stratified according to the newly developed digital pathology model.

  6. OS of HPV-negative HNSCC patients based on digital pathology model.

    Time frame: 6 months

    OS stratified according to the newly developed digital pathology model.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Licitra

CONTACT

[email protected]

+39 02 2390 2810

Stefano Cavalieri

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Other

Collaborators

  • Azienda Ospedaliero Universitaria di Sassari
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Istituto Europeo di Oncologia
  • Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
  • Pineta Grande Hospital, Castel Volturno (CE), Italy
  • San Raffaele University Hospital, Italy

Registry information

Official study title

Matching Primary Tumor and Blood Gene Expression Analysis of HPV-negative Squamous Head and Neck Cancers (BIOMATCH - Head and Neck)

Acronym: BIOMATCH

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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